Cesarean Section ComplicationsPhase 3ESPCSNCT04256642
Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia
A Phase 3 study testing Erector Spinae Plane Block and Intrathecal morphine in people with Cesarean Section Complications, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Erector Spinae Plane Block and Intrathecal morphine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2020to Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing scheduled Cesarean delivery
Who cannot join
- Patients with an ASA score greater than 3
- Allergies to study medications
- Contraindications to neuraxial analgesia
- Patients with chronic pain
- Patients unable to communicate in the study language
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec
Albert Moore, MD, moore_albert@hotmail.com
About this study
This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.
- Conditions
- Cesarean Section Complications
- Being tested
- Erector Spinae Plane Block, Intrathecal morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
A nerve block that injects local anesthetic in the Erector Spinae Plane
Intrathecal morphineDrug
Intrathecal morphine at the time of spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine | Active comparator | Not described Receives: Drug: Intrathecal morphine |
| Erector Spinae Plane Block | Experimental | Not described Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour area under the curve pain scores
It will be measured at 3 6 12 18 and 24 hours after the end of the cesarean delivery. This pain will be assessed by asking the patient to go from lying to sitting (or use incentive spirometry) and rated using a linear 10 cm visual analogue scale (VAS). The 24 hour pain VAS area under the curve (AUC) will be calculated using the trapezoid rule.
Measured: First 24 hour
Secondary outcomes (5)
Measurement of quality of recovery after cesarean delivery
At 24 hours the ObsQoR11, a validated instrument to measure the quality of recovery after cesarean delivery, will be administered to the patient
Measured: First 24 hours
Nausea and vomiting
The incidence of nausea and vomiting will be rated on a 10 cm VAS
Measured: First 24 hours
Analgesic usage
The cumulative use of opioids, expressed as morphine equivalents will be recorded at 24 hours.
Measured: First 24 hours
Pruritus
The incidence of pruritus will be rated on a 10 cm VAS
Measured: First 24 hours
Incidente of persistent surgical pain
Patients will be contacted by telephone 3 months after the cesarean to assess the presence of chronic pain. This will be done using a modification of the brief pain inventory
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University
- Responsible party
- Principal investigator, Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Albert Moore, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256642
- Sponsor's protocol ID
- 2020-5732
- Acronym
- ESPCS
- Status last verified
- Feb 2020
- First submitted
- 30 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia
- ClinicalTrials.gov ID
- NCT04256642
- Acronym / sponsor ID
- ESPCS / 2020-5732
- Conditions
- Cesarean Section Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Thammasat University
- Study start
- Feb 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine | Active comparator | Drug: Intrathecal morphine |
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane Block |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing scheduled Cesarean delivery
Key exclusion criteria (5 listed)
- Patients with an ASA score greater than 3
- Allergies to study medications
- Contraindications to neuraxial analgesia
- Patients with chronic pain
- Patients unable to communicate in the study language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockA nerve block that injects local anesthetic in the Erector Spinae Plane | Procedure or surgery | Erector Spinae Plane Block |
| Intrathecal morphineIntrathecal morphine at the time of spinal anesthesia | Drug | Intrathecal morphine |
Primary outcome
24 hour area under the curve pain scores
Time frame: First 24 hour
It will be measured at 3 6 12 18 and 24 hours after the end of the cesarean delivery. This pain will be assessed by asking the patient to go from lying to sitting (or use incentive spirometry) and rated using a linear 10 cm visual analogue scale (VAS). The 24 hour pain VAS area under the curve (AUC) will be calculated using the trapezoid rule.
5 secondary outcomes
Measurement of quality of recovery after cesarean delivery
Time frame: First 24 hours
Nausea and vomiting
Time frame: First 24 hours
Analgesic usage
Time frame: First 24 hours
Pruritus
Time frame: First 24 hours
Incidente of persistent surgical pain
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Moore, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erector Spinae Plane Block and Intrathecal morphine in people with Cesarean Section Complications, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Moore, MD (5149341934 ext. 34880, albert.moore@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour area under the curve pain scores (time frame: First 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.